Clinical Trials

Multiple AstraZeneca-sponsored Phase 1, Phase 2, and Phase 3 clinical trials—currently completed, recruiting, or active but not recruiting—evaluate the pharmacokinetic profile, safety, and therapeutic potential of AZD0780 for cardiovascular risk reduction. These studies investigate indications such as dyslipidemia, atherosclerotic cardiovascular disease, and heterozygous familial hypercholesterolemia, alongside evaluating blood pressure effects, lipid-lowering efficacy in combination therapy, and pharmacokinetics in healthy subjects and individuals with renal or hepatic impairment.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07000357 RECRUITING
Cardiovascular Disease
AstraZeneca
 2025-06-04 PHASE3
NCT07000123 ACTIVE_NOT_RECRUITING
Cardiovascular Disease
AstraZeneca
 2025-05-28 PHASE3
NCT07000136 ACTIVE_NOT_RECRUITING
Heterozygous Familial Hypercholesterolaemia
AstraZeneca
 2025-06-10 PHASE3
NCT07218900 ACTIVE_NOT_RECRUITING
Dyslipidaemia
AstraZeneca
 2025-11-13 PHASE2
NCT07513571 COMPLETED
Healthy Participants
AstraZeneca
 2026-04-10 PHASE1
NCT07423598 COMPLETED
Healthy Participants
AstraZeneca
 2026-02-24 PHASE1
NCT07216131 COMPLETED
Healthy Participants
AstraZeneca
 2025-11-10 PHASE1
NCT06742853 COMPLETED
Dyslipidemia
AstraZeneca
 2024-12-20 PHASE1
NCT06834932 ACTIVE_NOT_RECRUITING
Dyslipidaemia
AstraZeneca
 2024-12-06 PHASE2; PHASE3
NCT06692764 COMPLETED
Atherosclerotic Cardiovascular Disease
AstraZeneca
 2024-10-30 PHASE2
NCT06671405 COMPLETED
Dyslipidaemia
AstraZeneca
 2024-09-25 PHASE1
NCT06592482 COMPLETED
Renal Impairment
AstraZeneca
 2024-08-02 PHASE1
NCT06576765 COMPLETED
Hepatic Impairment
AstraZeneca
 2024-08-08 PHASE1
NCT06173570 COMPLETED
Dyslipidemia
AstraZeneca
 2024-01-19 PHASE2
NCT05384262 COMPLETED
Dyslipidemia
AstraZeneca
 2022-05-18 PHASE1
NCT05817461 COMPLETED
Cardiovascular Diseases
AstraZeneca
 2023-04-19 PHASE1
NCT05787002 COMPLETED
Dyslipidemia
AstraZeneca
 2023-03-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the AZD0780 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD0780 directly binds to proprotein convertase subtilisin/kexin type 9 (PCSK9) with nanomolar affinity, preventing PCSK9-mediated receptor degradation and increasing low-density lipoprotein receptor expression on hepatocyte cell membranes. This upregulation promotes hepatic clearance of circulating low-density lipoprotein particles, thereby significantly lowering serum cholesterol levels and demonstrating clinical utility for the treatment of dyslipidemia and atherosclerotic cardiovascular disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.